Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Operational Highlights

On November 6, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Wednesday, November 11, 2020, at 5:00 pm ET to discuss a corporate update and financial results for the third quarter of 2020 (Press release, Oncolytics Biotech, NOV 6, 2020, https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights-301167721.html [SID1234570203]).

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A live webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (855) 859-2056 (North America) or (416) 849-0833 (International) and using reference code: 678-8931.

Medison Pharma Enters Exclusive Distribution Agreement with Deciphera Pharmaceuticals to Commercialize QINLOCK® (Ripretinib) in a Multi-Regional Agreement

On November 6, 2020 Medison Pharma, a leading international commercial partner for highly innovative therapies, reported an exclusive distribution agreement with Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) to commercialize QINLOCK, a switch-control tyrosine kinase inhibitor, in Canada and Israel for the treatment of fourth-line gastrointestinal stromal tumor (GIST) (Press release, Medison Pharma, NOV 6, 2020, View Source [SID1234570202]).

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GIST is a cancer that occurs in the gastrointestinal tract, most commonly in the stomach or small intestine. QINLOCK has been approved in Canada as of June 2020 for the treatment of adult patients with GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and is expected to be launched by Medison Canada in Q4 2020. Medison Israel is planning to submit QINLOCK for registration during Q1 2021 and commence an early access program (EAP) for Israeli patients immediately after. QINLOCK has also been approved by the U.S. Food and Drug Administration (FDA) for fourth-line GIST.

"We are proud to join forces with Deciphera and share a joint commitment to making highly innovative therapies accessible to cancer patients. Our multi-territorial partnership enables Deciphera to accelerate the reach of its breakthrough oncology treatment to patients across markets," said Meir Jakobsohn, Founder and CEO of Medison Pharma.

"QINLOCK is a great fit for our portfolio and meets the growing need in Canada for cutting-edge therapies. Medison Canada is the only commercial partner in the Canadian market that focuses solely on providing access to life-saving, innovative therapeutics to Canadian patients," said Joe O’Neill, GM of Medison Canada.

"We are focused on bringing QINLOCK to people living with GIST around the world and are proud to be expanding the geographical reach of this important medicine to patients in Canada and Israel," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We look forward to partnering with Medison to provide patients and doctors with this much-needed therapeutic option for the treatment of advanced GIST."

Sumitomo Dainippon Pharma Oncology to Present New Data Evaluating Investigational Agent Alvocidib at 62nd ASH Annual Meeting

On November 6, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported that new data from the Phase 2 Zella 201 study evaluating the investigational agent alvocidib, a potent CDK9 inhibitor, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held virtually December 5-8, 2020 (Press release, Sumitomo Dainippon Pharma, NOV 6, 2020, View Source [SID1234570201]). Zella 201 is a biomarker-driven study of alvocidib followed by cytarabine and mitoxantrone in patients with relapsed/refractory MCL-1 dependent acute myeloid leukemia (AML). Data presented will include findings from an exploratory cohort of newly diagnosed, high-risk patients with MCL-1 dependent AML.

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"SDP Oncology has an unwavering dedication to exploring novel approaches to oncology research and development, with the goal of addressing unmet clinical needs. We look forward to reinforcing this commitment at the ASH (Free ASH Whitepaper) Annual Meeting as we share the latest data on our diverse pipeline of investigational cancer therapeutics," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "In particular, we are pleased to present preliminary efficacy data for the first time from this study arm which add to our growing understanding of the potential role of alvocidib combined with cytarabine and mitoxantrone in patients with MCL-1 dependent AML."

SDP Oncology and its parent company, Sumitomo Dainippon Pharma Co. Ltd., will also be presenting Phase 1 data evaluating alvocidib in combination with cytarabine and mitoxantrone in patients with relapsed/refractory AML or cytarabine and daunorubicin in patients with newly diagnosed AML. In addition, preclinical data evaluating how dubermatinib (TP-0903), an oral AXL kinase inhibitor, modulates CART19 function will be presented. Finally, SDP Oncology will be presenting details regarding the trial design of a Phase 1 study evaluating TP-3654, a PIM kinase inhibitor, in patients with intermediate-2 and high-risk primary or secondary myelofibrosis.

Below are the details for the SDP Oncology and Sumitomo Dainippon Pharma presentations:

Abstract Title

Details

Presenter

Zella 201: A Biomarker-Guided Phase II Study of Alvocidib Followed by Cytarabine and Mitoxantrone in MCL-1 Dependent Acute Myeloid Leukemia (AML): Results of Newly Diagnosed High-Risk Exploratory Arm

Abstract #1045

Saturday, December 5 at 7:00 a.m. PST

Virtual Poster Presentation

Joshua F. Zeidner, M.D.

University of North Carolina

A Phase 1 Study of TP-3654, an Orally-Delivered PIM Kinase Inhibitor, in Patients with Intermediate-2 or High-Risk Primary or Secondary Myelofibrosis

Abstract #1251

Saturday, December 5 at 7:00 a.m. PST

Virtual Poster Presentation

Claudia Lebedinsky, M.D.

Sumitomo Dainippon Pharma Oncology, Inc.

Axl-RTK Inhibition Modulates Monocyte Immune Response to Enhance the Anti-Tumor Effects of CD19 Redirected Chimeric Antigen Receptor T Cells in Preclinical Models

Abstract #1430

Saturday, December 5 at 7:00 a.m. PST

Virtual Poster Presentation

Reona Sakemura, M.D., Ph.D.

Mayo Clinic, Rochester, MN

Phase 1 Study of Alvocidib (DSP-2033) in Combination with Cytarabine/Mitoxantrone (ACM) or Cytarabine/Daunorubicin (A+7+3) in Japanese Patients (pts) with Acute Myeloid Leukemia (AML)

Abstract #2831

Monday, December 7 at 7:00 a.m. PST

Virtual Poster Presentation

Yasuyoshi Morita, M.D. Kindai University, Higashiosaka, Osaka, Japan

For more information about SDP Oncology’s pipeline and clinical trials, please visit the company’s virtual booth at the ASH (Free ASH Whitepaper) Annual Meeting.

About Alvocidib

Alvocidib is an investigational small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) currently being evaluated in the ongoing Phase 2 Zella 202 study in patients with acute myeloid leukemia (AML) who have either relapsed from or are refractory to venetoclax in combination with azacitidine or decitabine (NCT03969420). Alvocidib is also being evaluated in Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes (MDS) in combination with azacitidine or decitabine (NCT03593915) and in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax (NCT03441555).

About CDK9 Inhibition and MCL-1

MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.1 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.2 MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.1,3 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).4,5 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.4 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.1

About TP-3654

TP-3654 is an investigational second-generation selective PIM kinase inhibitor currently under evaluation in a Phase 1 study in patients with myelofibrosis (NCT04176198) and a Phase 1 study in patients with advanced solid tumors (NCT03715504).

About PIM Kinase

PIM kinases are major effectors of JAK/STAT proliferative signaling downstream of multiple growth factors and cytokines.6 PIM is overexpressed in cancers and it may enhance the ability of fibroblasts to differentiate into myofibroblasts.6

About Dubermatinib (TP-0903)

Dubermatinib is an investigational oral AXL receptor tyrosine kinase (RTK) inhibitor under evaluation in a Phase 1a/b study in patients with advanced solid tumors (NCT02729298) and an ongoing study in collaboration with the Leukemia & Lymphoma Society as part of the Beat AML Clinical Trial (NCT03013998). SDP Oncology is exploring parallel clinical development paths for dubermatinib in both solid and hematologic malignancies.

About AXL Kinase

AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers.7 It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion, and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.8

About Sumitomo Dainippon Pharma Oncology

Sumitomo Dainippon Pharma Oncology, Inc., is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. As a global oncology organization with teams in the U.S. and Japan, SDP Oncology is relentlessly committed to advancing purposeful science by transforming new discoveries into meaningful treatments for patients with cancer. The company’s robust and diverse pipeline of preclinical and advanced-stage assets spans multiple areas, including oncogenic pathways, survival mechanisms and novel protein interactions, which aim to address unmet clinical needs in oncology.

KDx Selects Acupath as Lab for URO17™ FDA Clinical Trial

On November 6, 2020 Acupath Laboratories, Inc., a leading provider of sub-specialized anatomic and molecular pathology services, and KDx Diagnostics, Inc., a leading developer of bladder cancer tests, reported that KDx has selected Acupath to process urine specimens for a formal FDA trial that kicked off in Q3. First offered in July 2019 as an LDT (Laboratory Developed Test) (Press release, Acupath Laboratories, NOV 6, 2020, View Source [SID1234570199]), Acupath was the first lab in the U.S. to offer URO17, a cost-effective urinary biomarker that improves on and adds value to traditional non-invasive diagnostic screening tests.

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Bladder cancer is the 6th most common cancer in the U.S., with 81,000 new cancer cases annually, and a 75% recurrence rate. One of the most common and inexpensive screening tests, urine cytology, is largely ineffective and pathologically subjective, with limited sensitivity and specificity.

The FDA trial currently underway will evaluate URO17 in conjunction with urine cytology and UroVysion FISH (Abbott Molecular). Several prominent LUGPA (Large Urology Group Practice Association) practices from across the US are participating as trial sites.

"Since launching in July 2019, our clients and patients have benefitted from the clinical information provided by URO17, which can serve as a valuable risk stratification tool, properly ruling in or out additional diagnostic tests," said John Cucci, Acupath’s Chief Sales & Strategy Officer. "We are excited about being chosen by KDx for the FDA trial, which possesses significant potential to addresses the deficiencies of current diagnostic tests."

"We excited that a patient enrollment for our clinical study has initiated and that the Acupath is our partner in this endeavor. Following up on our recent Breakthrough Device designation by the FDA and CE marking for URO17 test in Europe, we are moving ahead to obtain FDA clearance for this important test," said Nam W. Kim, Ph.D., CEO of KDx.

"As one of the most expensive cancer to treat, accurate non-invasive test for bladder cancer has a significant unmet medical need. Studies continue to show high sensitivity and specificity of URO17 in detecting bladder cancer through urine samples, confirming its clinical potential," said Sholeh Jahanfard, President and COO of KDx.

AcelRx Pharmaceuticals to Present at Credit Suisse 29th Annual Virtual Healthcare Conference

On November 6, 2020 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, reported that management will be presenting at the Credit Suisse 29th Annual Virtual Healthcare Conference to be held November 9 – 12 (Press release, AcelRx Pharmaceuticals, NOV 6, 2020, View Source [SID1234570198]). AcelRx management will provide an overview of the business and company updates during the live presentation and will be available for one-on-one meetings with investors.

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Details of the event are as follows:

Credit Suisse 29th Annual Virtual Healthcare Conference
Date: Tuesday, November 10, 2020
Presentation Time: 2 pm ET (11 am PT)

A live webcast link of the event can be found on the Company’s website at View Source For those not available to listen to the live broadcast, a replay will be archived for 90 days and available through the Investors page on www.acelrx.com.